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Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers

NCT ID: NCT00260325

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-04-30

Brief Summary

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Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the experiment.

Detailed Description

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Conditions

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Pain Hyperalgesia

Keywords

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pretreatment healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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valdecoxib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy male of non-pregnant female; 18yo or older
* not currently taking NSAID
* able and willing to provide informed consent
* willing to avoid other NSAIDs in 24 hour period following study
* no known hypersentitivites or contraindications to NSAIDS, sulfonomides or capsaicin

Exclusion Criteria

* pregnant or breast feeding
* use of NSAIDS or other analgesic medications in past 7 days
* unwilling or unable to give informed consent
* contraindication to any study medication or other NSAID
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Piotr K Janicki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University, Dept of Anesthesiology

Locations

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Penn State University College of Medicine

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IIG Pfizer(PJK)

Identifier Type: -

Identifier Source: secondary_id

MOIRR10732

Identifier Type: -

Identifier Source: secondary_id

70,328-01

Identifier Type: -

Identifier Source: org_study_id